Sterile surgical package



Oct. 1', 19682- T. A. DENNY: 3,403,776

SVTERILE SURGICAL PACKAGE Filed Mal-ch21, 1967' 27 INVENTOR Jhomas A. Dflru BY 7 W Cl. fir

ATTORNEY United States Patent 3,403,776 STERILE SURGICAL PACKAGE Thomas A. Denny, Edison, N.J., assignor to Johnson & Johnson, a corporation of New Jersey Filed Mar. 21, 1967, Ser. No. 624,784 2 Claims. (Cl. 20656) ABSTRACT OF THE DISCLOSURE A sterile surgical package for a plurality of surgical articles in which each article is situated in a compartment formed by two main panels which are sealed together at their periphery, and in which each interior main panel is common to two of said compartments so that as each article is in turn removed, one panel may be discarded without afiecting the sterility of the remaining articles.

From time to time during surgical and obstetrical procedures, sponges, swabs, skin clips, ligatures and the like are required for treatment of the patient, the same being discarded after use. Since these articles and instruments must be kept sterile, until the moment when they are used, they must be contained in a package which is bacteria impervious but which is easily openable. When it is time to use the packaged article the package is opened and the article or instrument extracted in an aseptic manner by the doctor or other members of the surgical team which have also scrubbed and are therefore considered sterile. More often than not, a plurality of a given article or instrument must be used during the surgical or obstetrical procedure. However, it is usually not known in advance exactly how many of the articles will be needed, and therefore it is necessary to keep a large number of the same on hand in the operating room. Similar problems are encountered during office procedures.

During the early days of package engineering this meant keeping a large number of packages on hand in the proximity of the operating table, Only one article being included in each package. Each package had to be opened and the sterile article extracted as the same was required in the procedure being carried out. When the operation was completed the remaining unopened bacteria impervious packages were returned to a central supply center for resteriliztion, primarly to eliminate bacteria on the outer surface of the same, and storage pending use during later surgical or obstetrical procedures.

The individual packaging of these articles leaves something to be desired in that it is not only expensive but also requires the time consuming opening of many such packages during the operation by operating room personnel whose services could otherwise be better utilized. In addition, a bulk quantity of these individually packaged articles consume an excessive amount of space in the operating room where space is at a premium. The volume of waste material created by individual packaging of articles used in large numbers from time to time created a waste disposal problem in the operating room.

Therefore, where the articles are fairly small, flat, and compact, such as are surgical sponges, swabs, and the like, it has become common practice to include two or more articles in one package. Thus the expense of packaging is reduced as is the space required for storing a bulk quantity of the articles and as is waste disposal. However, this packaging technique has also not been entirely satisfactory especially where the articles are to be used in oflice procedures. If all of the articles or instruments included in one of the Packages is not used, the unused articles nevertheless must be discarded after the procedure since the bacteria impervious nature of the package has been destroyed by the opening of the same.

In addition where a measurable period of time elapses between the successive use of each article contained in one opened package even during the same procedure, there is always some doubt as to whether or not the later used articles have become contaminated. In some cases the plurality of articles stick together in the package, thus making their individual aseptic removal difiicult, especially in the case of surgical sponges and the like made of cellulosic material. In removing one of these sponges from a package including a plurality of the same, the remaining sponges in the package are sometimes also removed and dropped to the floor, or some other contaminated surface.

Packages in the form of a compartmentalized tray and having double walled compartmentalizations perforated where the walls join, and having a bacteria impervious cover both perforated and sealed to the tray along a series of lines coinciding with the perforation lines in the compartmentalizations are also known in the art. As each article is needed that compartment is detached from the unit and individually opened. In a package of this type each compartment is in itself an integral package and therefore these trays amount to no more than a plurality of packages breakably connected together and solve none of the problems heretofore outlined.

It is therefore an object of the present invention to provide a package for a plurality of sterile surgical articles from which each article may be removed in turn without affecting the sterility of the remaining articles, and in which each article is contained in a bacteria impervious compartment having a wall common to at least one other such compartment.

It is a further object of this invention to provide a package of the type described above in which as each article is removed in turn therefrom, one of the walls forming the compartment from which the article was removed may be severed from the remainder of the package and discarded without effecting the sterility of the remaining articles.

It is a more specific object of this invention to provide a package having the above noted features for a plurality of flat, flexible articles such as surgical sponges and the like.

According to the present invention a sterile surgical package is provided comprising a plurality of bacteria impervious main panels, including two outer panels, and a plurality of sterile articles, each sterile article being disposed between at least two of the bacteria impervious main panels, each main panel other than the outer panels cooperating with at least two other adjacent main panels to define at least two adjacent bacteria impervious compartments for the sterile articles, each outer main panel cooperating with at least one other panel to define at least one bacteria impervious compartment for a sterile article, at least a portion of the connection of any main panel with any other main panel being a breakable connection by virtue of which an article access opening to each compartment may be provided as desired. Preferably the entire connection between any main panel and any other main panel is a breakable connection, whereby a sterile surgical package for a plurality of articles is provided in which any one of the sterile articles may be removed without affecting the sterility of the remaining articles and in which when each article is removed in turn, one of the main panels previously cooperating with another panel to form the bacteria impervious compartment from which the article was removed may be disconnected from its cooperating panel and discarded.

When adapting the above described invention to a package for fiat, thin articles such as surgical sponges and the like, the main package panels are suitably made of relatively flat, thin and flexible material and are of similar'size and shape, each main panel breakably sealed to each next adjacent main panel around its entire perimeter. In such an embodiment the seals between each main panel and its two adjacent main panels are preferably olfset from each other, and lie well inward of at least one edge of each panel to provide a stripping tab.

The invention may be better understood by referring to the appended drawings in which,

FIG. 1 is a plan view in perspective of a sterile surgical package for two surgical sponges and also shows the opening of one of the package compartments to gain access to one of said sponges.

FIG. 2 illustrates the package of FIG. 1 after one sponge has been removed and also shows the further opening of the package to gain access to the second sponge.

FIG. 3 is an end section of the package of FIG. 1 taken along line 33;

FIG. 4 is a cross section of the package of FIG. 1 taken along line 44;

FIG. 5 illustrates a sterile surgical package for three sterile sponges.

Referring now specifically to FIGS. l4, there is illustrated a surgical package 1 for two cotton gauze surgical sponges 2 and 3. The package 1 consist of two rectangular sheets of similar size of bacteria impervious, air pervious paper 4 and 5 and a rectangular sheet of polypropylene film 6. One sterile sponge is disposed between each paper sheet 4 and 5 and the polypropylene sheet 6. The paper sheets 4 and 5 are each sealed to the polypropylene sheet 6 in an area 7 and 8 around their entire periphery lying outward of the edges of the sponges 2 and 3 to form two sterile chambers 9 and 10 for the sponges 2 and 3. Each of the panels 4, 5, and 6 extends outward of the peripheral seals 7 and 8 at one end of the package to form hand grasping tabs 11, 12, and 13 which facilitate the opening of the package.

When the sponges are needed during a medical procedure, tabs 12 and 13 are suitably grasped with one one hand while tab 11 is pulled upward and backward with the other hand, as shown in FIG. 1, to expose at least a portion of one of the sponges 2. The sponge 2 may then be removed with a pair of forceps or the package may be turned upside down and the sponge dumped onto a sterile table. The nurse or doctor may then suitably continue to pull panel 4 backward to rupture the entire seal 7 between panel 4 and panel 6 and to sever the same from the package unit, the severed panel then being discarded.

The remaining portion of the package 1a, shown in FIGURE 2, is neat in appearance and can hardly is distinguished from an individual sponge package. The sterility of the remaining sponge 3 is not affected by the removal of the first sponge or the severing of panel 4 from the package unit. If the second sponge is not used, the remaining portion of the package may be returned to central supply to await resterilization and later use in the case of surgical procedure or simply utilized on the next patient in the case of ward procedures.

When it is desired to use the second sponge 3, the nurse suitably pulls panels 5 and 6 apart by using tabs 12 and 13 as illustrated in FIG. 2 thus exposing the second sponge. Again this sponge is either removed with a pair of forceps or dumped onto a sterile surface.

The package illustrated and described affords ready access to the sterile sponges incorporated therein and allows unused sponges to be used during subsequent procedures. Since each sponge compartment has a wall in common with at least one other sponge compartment, the package is much more economical from the standpoint of material costs than individual sponge packaging, and for the same reason the amount of waste in the operating room is decreased from to 50%. The package portion having the unused sponges is neat in appearance and has no unnecessary panels or elements remaining attached to the same, thus storage space requirements are again minimized.

When, as during ward procedures, a period of time elapses between the use of the two sponges, it can be assured that the second sponge remains sterile up until the time it is used.

While the invention has been and will continue to be described specifically with respect to fiat thin packages for fiat, thin, flexible articles such as surgical sponges and the like, the invention is not so restricted. Any plurality of sterile articles of any size and shape may be packaged according to the present invention and within the broad concepts of the same previously set out. However, it has been found that the invention can be used with particular advantage for the packaging of surgical sponges and the like, a large number of which are used during any one surgical procedure and which have to the greatest degree presented the problems previously outlined.

The package may be made from any bacteria impervious material as long as means are provided for sterilizing steam or gas to enter each of the article containing compartments. In the package shown in FIG. 1, the outer panels 4 and 5 consist of a paper sheet having a porosity sufiicient to readily permit the passage of air but will not ermit the passage of bacteria. This particular paper has a wet strength of 1.4 pounds per inch width, and a dry strength of 9 pounds per inch, a porosity as shown by the Gurley-Hill SPS tester of seconds.

The preferred papers have a porosity as shown by the Gurl-ey-I-Iill SPS tester of about 65 seconds to about 180 seconds. This method of porosity testing is the TAPPI Standard T460M49 and is the time for passage of milliliters of air through 1 square inch of paper. The porosity rating of any paper in terms of the above unit can be obtained from most manufacturers.

While these paper sheets are impervious to bacteria, steam and ethylene oxide gases may freely pass through the same and thus the sponges 2 and 3 may be sterilized. Since both outer panels are air pervious the center sheet 6 need not be air pervious. As illustrated, panel 6 advantageously consists of a thin polypropylene film. The use of such a thermoplastic film has the advantage that the seals between the center panel and outer panels may be effected by heat sealing techniques well known in the art. In addition when the center panel is transparent the surgical team may visually confirm the presence of the second sterile sponge after the first sponge has been used.

The various panels are suitably joined by an adhesive seal, preferably thermoplastic when a thermoplastic film is used in the package construction. A number of the panels can be made from a single folded sheet of paper if desired, however this makes it difficult to sever unneeded panels from the package unit as each sponge is in turn removed.

Since heat sealing does tend to weaken the polypropylene film in the sealed area, it is desirable that when a thermoplastic film is used the peripheral seals 7 and 8 between the sheet of film and any two sheets to which it may be joined be offset as illustrated in FIG. 1. Thus when the first paper sheet 4 is detached from the film 6, there will not be any tearing of the film or any rupturing of the seal between the film 6 and the next underlying sheet 5. In any case while the sealed area is advantageously at the periphery of the package panels well outward of the edges of the sterile articles, theseal should be substantially inward of the periphery of the package panels at at least one end of the package so that a hand grasping tab is provided to assist in the opening of the package.

Packages may be provided according to this invention for any number of sterile articles. In FIG. 5 there is illustrated a package 1 for three surgical sponges 21, 22, and 23. Each of the panels 24, 25, 26, and 27 is made of bacteria impervious paper and are sealed together in offset areas 28, 29, 30 at the periphery of the panels by adhesive means.

In some cases it will be desirable to package two different sterile articles both of which will be used in a single surgical procedure in the same package, thus the two articles may be used in turn as required without affecting the sterility of the second of the articles to be used.

What is claimed is:

1. A sterile surgical package comprising a plurality of relatively fiat, thin, flexible bacteria impervious main panels including two outer main panels and at least one interior main panel, and a plurality of sterile articles, each article being disposed between two main panels, no more than one of said main panels being impervious to the passage of air;

each interior main panel being breakably sealed to two adjacent main panels in a peripheral area outward of the edges of the sterile articles to define adjacent bacteria impervious compartments for sterile articles, and each outer main panel being breakably sealed to an interior main panel in a peripheral area outward of the edges of the sterile article to define a bacteria impervious compartment for a sterile article;

said breakable seals between any interior main panel and its adjacent main panels being offset from each other,

by virtue of which as each article is in turn removed from the package, one of the panels previously cooperating with a second panel to form the bacteria impervious compartment from which the article was removed may be disconnected from its cooperating panel and discarded without affecting the sterility of the remaining articles.

2. A relatively flat sterile surgical package comprising a first bacteria impervious panel, a transparent thermoplastic bacteria impervious second panel, and a third bacteria impervious panel, a relatively flat, thin first sterile article and a relatively fiat, thin second sterile article,

the first sterile article being disposed between the first panel and second panel and the second sterile article being disposed between the second panel and the third panel, at least two of said panels being pervious to the passage of air,

said first panel being breakably sealed to the second panel around its periphery and outward of the edges of the first sterile article and said third panel being breakably sealed to the second panel around its entire periphery, by virtue of said thermoplastic panel having been heat sealed to said first panel and second panel,

said seal between second panel and said first panel and said seal between said second panel and said third panel being offset seals,

whereby a sterile surgical package is provided containing a plurality of articles, from which one of the sterile articles may be aseptically removed without affecting the sterility of any of the remaining articles and in which as each article is removed in turn from the package a panel may be stripped from the package unit without affecting the sterility of the articles remaining in the package.

References Cited UNITED STATES PATENTS 2,77 9,465 1/ 1957 Anderson 206-47 3,061,087 10/ 1962 Serivens et al 20663.2 3,288,327 11/1966 Cahlik 206-56 XR FOREIGN PATENTS 613,527 1/1961 Canada. 873,341 4/ 1953 Germany.

JOSEPH R. LECLAIR, Primary Examiner.

THERON E. CONDON, Examiner.

J. M. CASKIE, Assistant Examiner. 

